NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-121738

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedMetastatic castration-resistant prostate cancer that has progressed following taxane-based therapy
Date of first enrollment01/3/2011
Target sample size1099
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Orteronel (TAK-700) Dosage And administration of the intervention : Oral Control intervention name : Placebo Dosage And administration of the control intervention : Oral

Outcome(s)

Primary OutcomeOverall survival (OS)
Secondary OutcomeRadiographic progression-free survival (rPFS), 50% prostate specific antigen (PSA) response, Pain response

Key inclusion & exclusion criteria

Age minimum18
Age maximum
GenderMale
Include criteria- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - Radiograph-documented metastatic disease - Progressive disease - Prior surgical castration or concurrent use of an agent for medical castration - Prior docetaxel therapy - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclude criteria- Documented central nervous system metastases - Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction - Uncontrolled cardiovascular condition as specified in study protocol - Uncontrolled nausea, vomiting or diarrhea

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name Takeda Pharmaceutical Company Limited OTAU Japan and Asia
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation